Miguel Burch, MD, of Cedars-Sinai in Los Angeles, offered a potential explanation for the lack of a large difference: patients in both groups had significant and frequent counseling with their physicians. Both met with their doctors 18 times for medical and device follow-up, and had an additional 17 educational counseling sessions that lasted 15 to 45 minutes each, Burch said.

"It would appear that the device required significant support, begging the question: which is more important, the device or the intensive follow-up?" Burch told MedPage Today. "I worry that this degree of support makes it hard to extrapolate even these modest results into the real-world settings most of us work in -- with continually fewer payers willing to 'invest' in resources."

Indeed, a body of literature supports the idea that face-to-face counseling is key to weight loss. The Endocrine Society recently published an obesity management guideline based on this literature that calls for 16 annual visits for weight-loss patients.

"We recommend that if you're going to treat weight management patients, that you see them frequently," Caroline Aprovian, MD, of Boston University, told reporters on a press call. "The best weight loss occurs with face-to-face visits."

Bourey noted that the 8.5% weight-loss gap is similar to the divergence between intensive and moderate lifestyle interventions in the first year of the Look AHEAD trial.

"The new and invasive technique of intra-abdominal intermittent vagal nerve blockade carries significant risk of pain and abdominal discomfort, but might deliver no better or even less weight loss than intensive exercise and diet," Bourey said.

Burch worked out the numbers. The mean baseline body mass index (BMI) in ReCharge was 41, representing an average excess weight of about 80 pounds.

"Thus, the average treatment arm patient would have lost 19.5 pounds compared to 12.7 pounds in the sham arm -- so 6.7 pounds separated the groups at 18 months," he said.

Several clinicians contacted by MedPage Today agreed that they prefer to wait for more data before prescribing the somewhat invasive treatment to their patients.

"If further studies demonstrate this technology to be comparable to currently accepted treatments, I would certainly be open to prescribing [it] to appropriately selected patients," said Michael Garren, MD, of the University of Washington. "Lacking further study, however, I would not."

Many also noted that the biology of the device is unclear, and that like other therapies, it may still only target one piece of the obesity puzzle.

"Obesity is a systems problem, caused by many biological, behavioral, social, cultural, environmental, and economic factors and relationships that are not addressed by this device," said Bruce Lee, MD, director of the Global Obesity Prevention Center at Johns Hopkins University.

Bartolome Burguera, MD, PhD, director of obesity programs at the Cleveland Clinic, noted that there are "multiple cerebral neurotransmitters and peripheral signals, which play a role in regulating appetite."

"There are also multiple causes responsible for overeating, and being hungry is just one of them," Burguera said. "The approach to obesity therapy is much more complicated than just down-regulating some gastrointestinal hormones. It would be important to see more data on levels of incretins and also weight maintenance."

Still, others note that the therapy does fill a gap in obesity treatment. New obesity drugs -- there have been four approved in the last few years, including Qsymia, Belviq, Contrave, and Saxenda -- can treat those on the lower end of the spectrum, while surgery can treat the most severe cases.

Patients who fall in the middle, or who don't want surgery, don't have many minimally invasive procedures to choose from, aside from the LapBand. Gastric balloon procedures common in Europe, while being investigated in the U.S., are not approved here.

"We need additional tools to help fill the gap of untreated people with class II and III obesity," said Mark Takata, MD, of the Scripps Center for Weight Management in La Jolla, Calif., who was involved in the EMPOWER study. "There are millions of people who have tried diets and medical weight management who qualify for existing bariatric surgical options who choose not to pursue such treatment for various reasons. Many of these patients will find VBLOC a very attractive option."

In exclusive interviews with MedPage Today, 12 obesity and surgical experts shared their thoughts on a new electrical stimulation device to treat obesity. For their full responses, click here.

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